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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Injury (2348); Numbness (2415); Ambulation Difficulties (2544); Disc Impingement (2655)
Event Date 08/15/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a clinical study regarding a patient with an implantable neurostimulator (ins). It was reported that the patient was experiencing back pain exacerbation. The hcp stated that the patient started having pain over their midline lower back wounds and on the right lateral back incision site. In addition, the patient had numbness, difficulty walking, and pain in their bilateral lower extremities. Interventions included hospitalization and medications administered. Diagnostic testing revealed multiple disc protrusions and enhancement of fluid around the ins. The etiology of the event was noted as not related to the device and possibly related to the therapy. The outcome of the event was noted as recovering/resolving. No further complications were reported or anticipated. Indication for use is spinal pain.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via manufacturer representative. It was reported that it was possible that the patient¿s multiple disc protrusions were related to the device or therapy. The manufacturer representative stated that the issues of back pain/lower back wounds, numbness, difficulty walking, disc protrusions, and fluid around the implant site have all been resolved. No further complications were reported or anticipated.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7814708
MDR Text Key118178488
Report Number3004209178-2018-19160
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/28/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/24/2018 Patient Sequence Number: 1
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